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Market Access

Integrated Evidence and Access Strategy to Launch a First-in-Class Rare Oncology Therapy

image of pharmacy community engagement activities
Client Profile

Mid-size Biopharmaceutical

Key Stakeholders

Market Access, HEOR, Medical Affairs

Asset

Phase III

Disease Area

Oncology

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Client Profile

Mid-size Biopharmaceutical

Key Stakeholders

Market Access, HEOR, Medical Affairs

Asset

Phase III

Disease Area

Oncology

Situation

A mid-size biopharmaceutical company was 18 months from launch of a therapy for a rare oncologic disease with no prior approved treatments.

Success would depend on more than approval. The team needed a clear value story, payer-relevant evidence, regulatory-aligned messaging, and strong positioning in clinical guidelines.

The client engaged Alkemi to develop and execute a coordinated evidence and communication strategy to support access and adoption at launch.

Approach

1. Developed an early value story mapping disease burden, unmet need, product value drivers, and evidence gaps.

2. Designed evidence generation initiatives, including RWE strategy and patient burden research to strengthen the value case.

3. Created a PRO-focused communications strategy to articulate the importance of the primary endpoint to regulators and investors.

4. Developed an AMCP dossier and payer-facing tools to support launch discussions.

5. Built guideline positioning communications to advocate for inclusion in clinical practice guidelines.

The focus throughout:

Align evidence, messaging, and payer strategy well before approval.

Deliverables

1
Early value story outlining burden, value drivers, and priority evidence gaps.
2
Evidence generation strategy to strengthen understanding of patient burden and clinical impact.
3
PRO communications strategy and tools to support regulatory and investor discussions.
4
AMCP dossier articulating value to payers at launch.
5
Guideline positioning communication tools to support inclusion in clinical practice guidelines.
6

Impact

"Alkemi helped us build a cohesive evidence and communication strategy that strengthened our value story and positioned us for a successful launch.” - Senior Director, Market Access

Rapid Guideline Inclusion:

A favorable NCCN guideline update advocating use of the therapy was issued within 10 days of approval.

Broad Payer Coverage:

The therapy secured coverage across major commercial and public U.S. payers.

Launch-Ready Alignment:

Integrated planning across evidence and access enabled a coordinated, confident market entry.

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